Vanda receives FDA not approvable letter for iloperidone

WilliamL. Watts

LONDON (MarketWatch) -- Vanda Pharmaceuticals
VNDA, -1.17%
on Monday said it had received a "not approvable" letter from the U.S. Food and Drug Administration in response to its new drug application for iloperidone, an antipsychotic drug reviewed for the treatment of schizophrenia. A not approvable letter describes deficiencies that prevent approval unless corrected. "We are disappointed by this response, but will meet with the FDA to discuss this decision further," said Vanda CEO Mihael H. Polymeropoulos, in a news release. Vanda said it has put all iloperidone-related activities on hold pending further review. The Rockville, Md.-based company scheduled a Monday conference call at 10:30 a.m. Eastern to discuss the FDA response.

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